WASHINGTON DC, May 27 /PRNewswire/ -- Bavarian Nordic, the Danish-based biopharmaceutical company, has initiated a Phase I/II clinical study with its HIV vaccine candidate: MVA-BN(R) HIV multiantigen.
Enrolment in a Phase I/II safety and immunogenicity study in 15 HIV-infected patients (CD4 counts >350 ul/ml) has begun in the United States. The first safety data is expected by the end of 2008 and immunogenicity data will be available during first half of 2009.
The MVA-BN(R) HIV multiantigen vaccine encodes eight genes from HIV, including Nef and thus represents a more advanced vaccine candidate compared to Bavarian Nordic's previous MVA-based HIV vaccine candidates, MVA HIV nef and MVA-BN(R) HIV polytope. In previous clinical studies with MVA HIV nef, Bavarian Nordic has demonstrated proof-of-concept for the MVA technology's ability to control HIV replication. Furthermore the vaccine was shown to be immunogenic and to induce a broad T-cell response to Nef. The MVA-BN(R) HIV multiantigen builds on these positive results and thus represents an excellent opportunity to stimulate a broad immune response to the majority of the HIV proteins that will likely have important implications in a prophylactic and therapeutic setting for HIV.
Anders Hedegaard, President & CEO of Bavarian Nordic, commented: "Our strong expertise in HIV vaccine development has expedited the development of the multiantigen vaccine. It is exciting that we now again are in clinical development with an HIV vaccine candidate. The HIV multiantigen program indeed benefits from the data generated in our previous HIV studies, demonstrating a unique safety profile of MVA in this high-risk population, as well as the potential to control HIV replication."
About Bavarian Nordic:
Bavarian Nordic, headquartered in Denmark, is a leading international biopharmaceutical company developing and producing innovative vaccines to prevent and treat infectious diseases and cancer.
In the U.S., Bavarian Nordic operates subsidiary companies, BN ImmunoTherapeutics, in Mountain View, California developing vaccines against cancers, and Bavarian Nordic Inc. in Washington, D.C. focused on business development, marketing, and government relations for the Bavarian Nordic Group.
For more information on Bavarian Nordic visit: http://www.bavarian-nordic.com
"Safe Harbour" Statement under the Private Securities Litigation Reform Act of 1995": Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. No "forward-looking statement" can be guaranteed, and actual results may differ materially from those projected. Bavarian Nordic undertakes no obligation to publicly update any "forward-looking statement", whether as a result of new information, future events, or otherwise. Additional information regarding risks and uncertainties is set forth in the current Annual Report and in Bavarian Nordic's periodic reports, if any, which we incorporate by reference.
Contact: Anders Hedegaard, President & CEO +45-33-26-83-83.
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